the effects of glucose control and weight loss between beinaglutide and dulaglutide in type 2 diabetes with overweight or obesity.

Conditions: Diabetes Mellitus, Type 2; Overweight or Obesity

Summary: this study is a multi-center, open label, randomized controlled trial that main purpose of this study is to evaluate the differences of glucose control and weight loss between beinaglutide and dulaglutide in type 2 diabetes with overweight or or obesity.

about 2/3 of patients with type 2 diabetes are overweight or obese in china, several studies had confirmed that overweight and obesity could cause type 2 diabetes. glp-1 receptor agonist could control diabetes meanwhile loss the patient weight. this is a multi-center, openlabel, 1:1 randomized controlled trial to investigate the differences of glucose control and weight loss between two glp-1 receptor agonist, beinaglutide and dulaglutide, in type 2 diabetes with overweight or obesity. the study comprises the 0-2 weeks of screening period and the 16-week intervention period. 120 patients according to the inclusion/exclusion criteria would recruit from 4 sites in china, then the participant will be randomized to three times a day of subcutaneous beinaglutide(dose escalate to 0.2mg), or once-weekly of 1.5mg subcutaneous dulaglutide for 16-week. the primary endpoint is the change from baseline to week 16 in hba1c. the second endpoint is the change from baseline to week 16 in weight.

Eligibility criteria:
inclusion criteria: 1. age between 18 to 70 years old from all sex; 2. diagnosed with type 2 diabetes and hba1c between 7% to 10%; 3. bmi from 24 to 35kg/m² or waistline longger than 90cm（male）/85cm（female）; 4. volunteer to participate in the study with informed consent; exclusion criteria: 1. type 1 diabetes or other specific types of diabetes; 2. taking drugs of glp-1 receptor agonist、tzds and sglt2 inhibitor within 3 months of screening; 3. taking insulin or insulin analogues more than 7 days within 3 months of screening; 4. pregnancy, breastfeeding or planned pregnancy; 5. history of acute or chronic pancreatitis; 6. taking glucocorticoids(oral or intravenous) continuously more than 7 days within 6 months of screening; 7. alanine aminotransferase or aspartate transaminase more than 3 times of the normal upper limit, total bilirubin more than 2 times of the normal upper limit; 8. renal impairment (estimated glomerular filtration rate\<60ml/min per 1.73 m²); 9. history of gastrointestinal disease; 10. history of malignant tumor within 5 years of screening; 11. history of organ transplantation or aids; 12. history of glaucoma; 13. history of hyperthyroidism or hypothyroidism; 14. history of medullary thyroid carcinoma or multiple endocrine neoplasia ii; 15. history of abnormal of calcitonin or thyroid tumor; 16. history of alcohol abuse; 17. recruited by other clinical trials within 3 months of screening; 18. taking drugs of weight loss within 3 months of screening; 19. history of bariatric surgery; 20. history of mental disorders; 21. history of rheumatic diseases or autoimmune diseases; 22. allergic to beinaglutide or dulaglutide; 23. participants who estimated would not be suitable for the study by the investigators.

Keywords: glp-1 receptor agonist beinaglutide dulaglutide type 2 diabetes hba1c